PlainRecalls
FDA Drug Critical Class I Ongoing

Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.

Reported: February 28, 2024 Initiated: January 12, 2024 #D-0333-2024

Product Description

Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.

Reason for Recall

Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.

Details

Recalling Firm
Neptune Resources, LLC
Units Affected
1,000,000 bottles
Distribution
Nationwide in the USA
Location
Kansas City, MO

Frequently Asked Questions

What product was recalled?
Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.. Recalled by Neptune Resources, LLC. Units affected: 1,000,000 bottles.
Why was this product recalled?
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 28, 2024. Severity: Critical. Recall number: D-0333-2024.